Microbiology FDA 483 (STAQ Pharma) : Aseptic processing areas are deficient regarding the system for monitoring environmental conditions
Observation
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Firm / Company
STAQ Pharma of Ohio, LLC
System
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Specifically,
The location of your viable and nonviable particle sample collection points inside your ISO-5 *** Laminar Flow Hood in room *** is inadequate as they are situated directly adjacent to the HEPA air filter grate at the back of the hood. Samples collected evaluate only the air flowing immediately out of the HEPA filter, not air that is representative of the operational sterile filling area where *** aseptic filling manipulations are being conducted.
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FDA 483 relevant to Microbiology
Disclaimer: The purpose of this article is to provide helpful information on FDA 483s related to microbiological issues. This article represents 483 information in Tabular form for quick access and easy navigation. Information for this article is derived from “Form FDA 483” (Inspectional Observation). This article is not intended to replace the information provided by the FDA, nor is it guaranteed to be complete, always refer official FDA site for details.